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Yki-Jrvinen, H., Fatty liver: a novel component of the metabolic syndrome

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As described in the statistical analysis plan, for the single-dose part of the study, assuming an anti-GDF8 + anti-ActA combination treatment effect of 6% over placebo in thigh muscle volume by MRI and an anti-GDF8 alone treatment effect of 3% over placebo, sample sizes of 12 for the anti-GDF8 + anti-ActA combination, six for anti-GDF8 alone, and 12 for placebo (pooled) were estimated to provide 99% power in demonstrating a treatment difference between the anti-GDF8 + anti-ActA combination final dose and placebo at a two-sided 0.05 level based on an assumed common standard deviation of 3%

Guyatt GH, Oxman AD, Vist G, Kunz R, Brozek J, Alonso-Coello P, Montori V, Akl EA, Djulbegovic B, Falck-Ytter Y, et al